AG Hair Limited

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Passage 3

Your firm failed to establish adequate laboratory controls including microbiological testing and specifications for all of your non-sterile drug products. For example, your firm failed to conduct microbiological testing of your Hands Free Clean Hand Sanitizer Gel drug product prior to release. Additionally, while microbiological testing is conducted on your **(b)(4)** drug product prior to release; your standard plate count specification is not appropriate for the intended use of the product.

Passage 4

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 5

You failed to perform adequate identity testing for each component lot used in the production of your hand sanitizer drug products, including ethanol, your active pharmaceutical ingredient. Additionally, your active pharmaceutical ingredient, ethanol, is not tested for methanol content, and your procedures did not ensure that you test glycerin for presence of diethylene glycol (DEG).